Convictions in Unapproved Sterilization Device Scheme
MedSun: Newsletter #4, May 2006
Two executives of a Mundelein, IL, company were convicted April 13, 2006, of fraudulently selling uncleared surgical sterilizing devices that led to eye damage in 18 patients, causing them to lose sight in one eye.
Ross Caputo was president and chief executive officer of AbTox and Robert Riley was vice president of regulatory affairs of AbTox when the company received permission to market a small gas plasma sterilizer only for use in sterilizing flat stainless-steel surgical instruments without lumens (tubes) or hinges. The defendants instead marketed a larger, unauthorized version of the sterilizer and promoted its use for a wide array of nonstainless-steel instruments.
Hospitals that purchased the larger unauthorized units were shown by AbTox the clearance letter for the smaller, authorized unit. These larger units were used in an unauthorized manner—because AbTox marketed them that way—to sterilize complex instruments, including cataract instruments that have small tubes used to put solution into the patient’s eye. One unauthorized use was to sterilize ophthalmic instruments that had brass joints, which reacted to the sterilizing agent creating a toxic residue. AbTox knew of the reaction but did not advise users or seek proper corrective action. The blindness was caused by a harmful copper acetate residue that remained in the tube of the instrument after sterilization by this machine.
The company sold 168 of the unauthorized units to hospitals nationwide, including U.S. Department of Veterans Affairs hospitals and other government agencies, totaling over $18 million in sales. Hospitals in Chicago, IL, Columbia, MO, and St. Louis, MO, reported to AbTox that their sterilizers were suspected of causing injuries to several patients. The company failed to notify the FDA about these reports as required.
“These convictions are evidence of the [Food and Drug Administration’s (FDA)] resolve to ensure the safety and efficacy of human medical devices. Our criminal investigators aggressively pursue those that endanger the public health by manufacturing and selling unsafe products,” said Margaret O’K. Glavin, the FDA Associate Commissioner for Regulatory Affairs.
The conviction of these two men is the result of an investigation conducted by the FDA Office of Criminal Investigations. The defendants were convicted of three counts of wire fraud, four counts of mail fraud, seven counts of selling an adulterated (unapproved) or misbranded (mislabeled) human medical device, and conspiracy to defraud the FDA. Mr. Riley was also convicted of one count of making a false statement for lying to the FDA.
The defendants face significant penalties, including incarceration, fines, and restitution. Sentencing will be at a later date. Two other defendants, Mark E. Schmitt, former AbTox director of marketing, and Marilyn M. Lynch, former AbTox director of clinical services, previously pleaded guilty in this case.
The defendants were found guilty after a 9-week trial in the Northern District of Illinois as the result of a successful prosecution under the direction of Patrick J. Fitzgerald, United States Attorney for the Northern District of Illinois, in conjunction with the U.S. Department of Veterans Affairs Office of Inspector General, Office of Investigations; the U.S. Naval Criminal Investigative Service; and the U.S. Air Force Office of Special Investigations; along with the FDA.
For this FDA press release go to: